Clause 3 Article 1 of Circular No. 23/2023/TT-BYT has amended Clause 2 Article 5 of Circular No. 01/2018/TT-BYT as follows:
- Imported drugs that have been granted marketing authorization in Vietnam and have package inserts in the Vietnamese language contained in their commercial packages but have been not yet updated with compulsory information as regulated by the Ministry of Health of Vietnam, except the cases where package inserts are exempted according to provisions of Points a, b, c, and d Clause 1 Article 13 of Circular No. 01/2018/TT-BYT;
- Imported drugs that are not yet granted marketing authorization in Vietnam and do not have package inserts in the Vietnamese language contained in their commercial packages, except in the cases where package inserts are exempted according to provisions of Points a, b, c, d, and dd Clause 1 Article 13 of Circular No. 01/2018/TT-BYT.
- Imported drugs that have been granted marketing authorization by the Ministry of Health of Vietnam for national defense and security, epidemic prevention and control, disaster or calamity recovery purposes, and do not have package inserts in the Vietnamese language contained in their commercial packages.
(Previously, Clause 2 Article 5 of Circular No. 01/2018/TT-BYT stipulated:
- Imported drugs that have been granted marketing authorization in Vietnam and have package inserts in the Vietnamese language contained in their commercial packages but have been not yet updated with compulsory information as regulated by the Ministry of Health of Vietnam, except the cases where package inserts are exempted according to provisions of Points a, b, c, and d Clause 1 Article 13 of Circular No. 01/2018/TT-BYT;
- Imported drugs that are not yet granted Marketing Authorization in Vietnam and do not have package inserts in the Vietnamese language contained in their commercial packages, except for the cases where package inserts are exempted according to regulations in Points a, b, c, d, and dd Clause 1 Article 13 of Circular No. 01/2018/TT-BYT dated January 18, 2018.)
See more details in Circular No. 23/2023/TT-BYT effective as of January 15, 2024.
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Above are the summary and notification of new documents for customers of THU VIEN PHAP LUAT. For more information, please send an email to [email protected].
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